Prosthetic heart valve assembly

ABSTRACT

A prosthetic heart valve assembly includes a self-expandable stent having an inlet end and an outlet end and a passageway extending therethrough. The stent includes a plurality of rows of prongs on the outer surface of the stent. A valve portion comprising a plurality of leaflets is positioned within the passageway for permitting blood to flow through the passageway from the inlet end to the outlet end while blocking flow in the opposite direction. The stent further includes a flared upper portion shaped for placement along a supra-annular surface of an annulus for preventing downward migration of the prosthetic valve assembly into a ventricle. Each of the prongs has a tip pointing toward the inlet end for penetrating surrounding tissue and preventing upward migration of the prosthetic heart valve assembly toward an atrium.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/238,344, filed Jan. 2, 2019, now U.S. Pat. No. 10,952,846, which is acontinuation of U.S. patent application Ser. No. 15/683,611, filed Aug.22, 2017, now U.S. Pat. No. 10,617,520, which is a continuation of U.S.patent application Ser. No. 14/584,903, filed Dec. 29, 2014, now U.S.Pat. No. 10,226,334, which is a continuation of U.S. patent applicationSer. No. 13/660,875, filed Oct. 25, 2012, now abandoned, which is acontinuation of U.S. patent application Ser. No. 12/113,418, filed May1, 2008, now abandoned, each of which is incorporated by referenceherein.

FIELD

The present disclosure concerns a prosthetic mitral heart valve and amethod for implanting such a heart valve.

BACKGROUND

Prosthetic cardiac valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary and mitral valves) serve critical functions in assuring theforward flow of an adequate supply of blood through the cardiovascularsystem. These heart valves can be rendered less effective by congenital,inflammatory or infectious conditions. Such damage to the valves canresult in serious cardiovascular compromise or death. For many years thedefinitive treatment for such disorders was the surgical repair orreplacement of the valve during open heart surgery, but such surgeriesare prone to many complications. More recently a transvascular techniquehas been developed for introducing and implanting a prosthetic heartvalve using a flexible catheter in a manner that is less invasive thanopen heart surgery.

In this technique, a prosthetic valve is mounted in a crimped state onthe end portion of a flexible catheter and advanced through a bloodvessel of the patient until the valve reaches the implantation site. Thevalve at the catheter tip is then expanded to its functional size at thesite of the defective native valve such as by inflating a balloon onwhich the valve is mounted.

Another known technique for implanting a prosthetic aortic valve is atransapical approach where a small incision is made in the chest wall ofa patient and the catheter is advanced through the apex (i.e., bottomtip) of the heart. Transapical techniques are disclosed in U.S. PatentApplication Publication No. 2007/0112422, which is hereby incorporatedby reference. Like the transvascular approach, the transapical approachincludes a balloon catheter having a steering mechanism for delivering aballoon-expandable prosthetic heart valve through an introducer to theaortic annulus. The balloon catheter includes a deflecting segment justproximal to the distal balloon to facilitate positioning of theprosthetic heart valve in the proper orientation within the aorticannulus.

The above techniques and others have provided numerous options forhigh-risk patients with aortic valve stenosis to avoid the consequencesof open heart surgery and cardiopulmonary bypass. While procedures forthe aortic valve are well-developed, such procedures are not necessarilyapplicable to the mitral valve.

Mitral valve repair has increased in popularity due to its high successrates, and clinical improvements noted after repair. However, asignificant percentage (i.e., about 33%) of patients still receiveopen-heart surgical mitral valve replacements due to calcium, stenosis,or anatomical limitations. There are a number of technologies aimed atmaking mitral repair a less invasive procedure. These technologies rangefrom iterations of the Alfieri stitch procedure to coronary sinus-basedmodifications of mitral anatomy to subvalvular placations or ventricularremodeling devices, which would incidentally correct mitralregurgitation.

However, for mitral valve replacement, few less-invasive options areavailable. There are approximately 60,000 mitral valve replacements(MVR) each year and it is estimated that another 60,000 patients shouldreceive MVR, but are denied the surgical procedure due to risksassociated with the patient's age or other factors. One potential optionfor a less invasive mitral valve replacement is disclosed in U.S. PatentApplication 2007/0016286 to Herrmann. However, the stent disclosed inthat application has a claw structure for attaching the prosthetic valveto the heart. Such a claw structure could have stability issues andlimit consistent placement of a transcatheter mitral replacement valve.

Accordingly, further options are needed for less-invasive mitral valvereplacement.

SUMMARY

A prosthetic mitral valve assembly and method of inserting the same isdisclosed.

In certain disclosed embodiments, the prosthetic mitral valve assemblyhas a flared upper end and a tapered portion to fit the contours of thenative mitral valve. The prosthetic mitral valve assembly can include astent or outer support frame with a valve mounted therein. The assemblyis adapted to expand radially outwardly and into contact with the nativetissue to create a pressure fit. With the mitral valve assembly properlypositioned, it will replace the function of the native valve.

In other embodiments, the mitral valve assembly can be inserted above orbelow an annulus of the native mitral valve. When positioned below theannulus, the mitral valve assembly is sized to press into the nativetissue such that the annulus itself can restrict the assembly frommoving in an upward direction towards the left atrium. The mitral valveassembly is also positioned so that the native leaflets of the mitralvalve are held in the open position.

In still other embodiments, when positioned above the annulus, prongs orother attachment mechanisms on an outer surface of the stent may be usedto resist upward movement of the mitral valve assembly. Alternatively(or in addition), a tether or other anchoring member can be attached tothe stent at one end and secured to a portion of the heart at anotherend in order to prevent movement of the mitral valve assembly afterimplantation. A tether may also be used to decrease the stress on theleaflets of the replacement valve and/or to re-shape the left ventricle.

In still other embodiments, the prosthetic mitral valve assembly can beinserted using a transapical procedure wherein an incision is made inthe chest of a patient and in the apex of the heart. The mitral valveassembly is mounted in a compressed state on the distal end of adelivery catheter, which is inserted through the apex and into theheart. Once inside the heart, the valve assembly can be expanded to itsfunctional size and positioned at the desired location within the nativevalve. In certain embodiments, the valve assembly can be self-expandingso that it can expand to its functional size inside the heart whenadvanced from the distal end of a delivery sheath. In other embodiments,the valve assembly can be mounted in a compressed state on a balloon ofthe delivery catheter and is expandable by inflation of the balloon.

These features and others of the described embodiments will be morereadily apparent from the following detailed description, which proceedswith reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a stent used in certain embodiments of amitral valve assembly.

FIGS. 2A and 2B are a perspective views an embodiment of a mitral valveassembly using the stent of FIG. 1 , as viewed from the top and bottom,respectively, of the assembly.

FIG. 3 is a cross-sectional view of a heart with the mitral valveassembly of FIG. 2 implanted within the native mitral valve.

FIG. 4 is an enlarged cross-sectional view of a heart with an embodimentof the mitral valve assembly implanted below an annulus of the nativemitral valve.

FIG. 5 is an enlarged cross-sectional view of a heart with an embodimentof the mitral valve assembly implanted within the native mitral valvewherein a tether is attached to the stent for preventing migration ofthe mitral valve assembly.

FIG. 6 is a perspective view of a mitral valve assembly having externalanchoring members to assist in securing the mitral valve assembly to thesurrounding tissue.

FIG. 7 is a perspective view of an embodiment of a stent having ascalloped end portion.

FIGS. 8A-8D are cross-sectional views showing an embodiment of themitral valve assembly inserted using a transapical procedure.

FIG. 9 is a perspective view of an embodiment of a prosthetic valveassembly having tensioning members coupled to prosthetic leaflets of thevalve to simulate chordae tendinae.

FIG. 10 is a perspective view of a prosthetic valve assembly havingtensioning members, according to another embodiment.

FIG. 11 is a perspective view of a prosthetic valve assembly havingtensioning members, according to another embodiment.

FIG. 12 is a perspective view of a prosthetic valve assembly having abicuspid valve, according to another embodiment.

FIG. 13 is a top view of the prosthetic valve assembly of FIG. 12 withthe bicuspid valve in a closed or at-rest position.

FIG. 14 is a top view of the prosthetic valve assembly of FIG. 12 withthe bicuspid valve in an open position.

FIG. 15 is a perspective view of a prosthetic valve assembly havingtensioning members coupled to a bicuspid valve in a closed position,according to another embodiment.

FIG. 16 is a perspective view of the prosthetic valve assembly of FIG.15 with the bicuspid valve in an open position.

FIG. 17 is a cross-sectional view of a prosthetic valve assembly havinga non-uniform cross-sectional shape.

DETAILED DESCRIPTION

As used herein, the singular forms “a,” “an,” and “the” refer to one ormore than one, unless the context clearly dictates otherwise.

As used herein, the term “includes” means “comprises.” For example, adevice that includes or comprises A and B contains A and B but canoptionally contain C or other components other than A and B. A devicethat includes or comprises A or B may contain A or B or A and B, andoptionally one or more other components such as C.

FIG. 1 is a perspective view of a stent 10 configured for placement in anative mitral valve. The stent in this embodiment includes an upperportion 12 having an enlarged or flared end 14 that tapers to a lowerportion 16 having a reduced diameter. The stent generally has a bellshape or a truncated conical shape, but other shapes can be used. Thestent 10 can have a continuous taper from the flared end 14 to the lowerend 15. As described below, at least the upper portion desirably tapersin a direction from the upper end to the lower end 15 so as to generallyconform to the contours of the native leaflets to assist in securing thestent within the native valve. In some embodiments, the portion of thestent extending below the native leaflets can have a generallycylindrical shape or could further taper. Additionally, the length ofthe stent 10 can vary. In some embodiments the stent can be between15-50 mm in length. For example, specific testing has been performed onstents having lengths of 24 mm and 46 mm in length. A circumference ofthe stent 10 varies along a length thereof, but is generally sized forreceiving a bicuspid or tricuspid valve. An example circumference of thestent at a point in the upper portion is 30 mm, but other sizes can beused depending on the desired valve. The stent can be a self-expandingstent formed from a shape memory material, such as, for example,Nitinol. In the illustrated embodiment, the stent is formed frommultiple somewhat arcuate-shaped fibers extending along the length ofthe stent with approximately half of the fibers bent in a firstdirection and half of the fibers bent in a second direction to create acrisscross pattern. As explained further below, the stent can bedelivered in a radially-compressed state using an introducer, such thatafter reaching the treatment site, it is advanced out of the distal endof the introducer and expands to its functional size in a relaxed statein contact with the surrounding tissue. A specific example of such atechnique is shown and described below in relation to FIGS. 8A-8D.

In other embodiments, the stent 10 can be a balloon-expandable stent. Insuch a case, the stent can be formed from stainless steel or any othersuitable materials. The balloon-expandable stent can be configured to becrimped to a reduced diameter and placed over a deflated balloon on thedistal end portion of an elongate balloon catheter, as iswell-understood in the art.

The flared end 14 of the stent 10 helps to secure the stent above orbelow the annulus of the native mitral valve (depending on the procedureused), while the tapered portion is shaped for being held in place bythe native leaflets of the mitral valve.

FIGS. 2A and 2B are perspective views of the stent 10 with a valve 18inserted therein to form a mitral valve assembly 20. The valve 18 canhave a leafed-valve configuration, such as a bicuspid valveconfiguration or the tricuspid valve configuration shown in theillustrated embodiment. As shown in FIG. 2B, the valve 18 can be formedfrom three pieces of flexible, pliant material connected to each otherat seams 60 (also referred to as commissure tabs) to form collapsibleleaflets 62 and a base, or upper end, portion 64. The valve 18 can beconnected to the stent 10 at the seams 60 using, for example, sutures orother suitable connection techniques well-known in the art.Alternatively, the valve 18 can be a mechanical type valve, rather thana leafed type valve.

The valve 18 can be made from biological matter, such as natural tissue,pericardial tissue (e.g., bovine, porcine or equine pericardium), aharvested natural valve, or other biological tissue. Alternatively, thevalve can be made from biocompatible synthetic materials (e.g.,biocompatible polymers), which are well known in the art. The valve canbe shaped to fit the contours of the stent so as to have a flared upperend portion having an upper circumference larger than a lowercircumference at the lower end of the valve. Blood flow through thevalve proceeds in a direction from the upper portion 12 to the lowerportion 16, as indicated by arrow 22 (FIG. 2A).

FIG. 3 shows a cross-sectional view of a heart with the prostheticmitral-valve assembly inserted into the native mitral valve. Forpurposes of background, the four-chambered heart is explained further.On the left side of the heart, the native mitral valve 24 is locatedbetween the left atrium 26 and left ventricle 28. The mitral valvegenerally comprises two leaflets, an anterior leaflet 24 a and aposterior leaflet 24 b. The mitral valve leaflets are attached to amitral valve annulus 30, which is defined as the portion of tissuesurrounding the mitral valve orifice. The left atrium 26 receivesoxygenated blood from the pulmonary veins. The oxygenated blood that iscollected in the left atrium 26 enters the left ventricle 28 through themitral valve 24.

Contraction of the left ventricle 28 forces blood through the leftventricular outflow tract and into the aorta 32. The aortic valve 34 islocated between the left ventricle 28 and the aorta 32 for ensuring thatblood flows in only one direction (i.e., from the left ventricle to theaorta). As used herein, the left ventricular outflow tract (LVOT) isintended to generally include the portion of the heart through whichblood is channeled from the left ventricle to the aorta.

On the right side of the heart, the tricuspid valve 40 is locatedbetween the right atrium 42 and the right ventricle 44. The right atrium42 receives blood from the superior vena cava 46 and the inferior venacava 48. The superior vena cava 46 returns de-oxygenated blood from theupper part of the body and the inferior vena cava 48 returnsde-oxygenated blood from the lower part of the body. The right atrium 42also receives blood from the heart muscle itself via the coronary sinus.The blood in the right atrium 42 enters into the right ventricle 44through the tricuspid valve 40. Contraction of the right ventricleforces blood through the right ventricle outflow tract and into thepulmonary arteries. The pulmonic valve 50 is located between the rightventricle 44 and the pulmonary trunk for ensuring that blood flows inonly one direction from the right ventricle to the pulmonary trunk.

The left and right sides of the heart are separated by a wall generallyreferred to as the septum 52. The portion of the septum that separatesthe two upper chambers (the right and left atria) of the heart is termedthe atrial (or interatrial) septum while the portion of the septum thatlies between the two lower chambers (the right and left ventricles) ofthe heart is called the ventricular (or interventricular) septum. Ahealthy heart has a generally conical shape that tapers from a base toan apex 54.

As shown in FIG. 3 , the mitral valve assembly 20 is positioned suchthat the flared end 14 of the upper portion 12 is adjacent the annulus30 of the native mitral valve 24, while the leaflets of the native valvebear against and hold the tapered upper end portion 12 of the mitralvalve assembly. The prosthetic mitral valve assembly of FIG. 3 ispreferably positioned with the flared end 14 above or just below anannulus 30 of the native mitral valve. The valve assembly is configuredto form a “pressure fit” with the surrounding native valve tissue; thatis, the outward radial pressure of the stent bears against thesurrounding tissue to assist in retaining the valve assembly in place.

FIG. 4 is enlarged view of the mitral valve assembly 20 positioned belowthe annulus 30 of the native mitral valve 24. In particular, the flaredend 14 of the stent is tucked under the annulus 30 of the native mitralvalve (under the insertion point of the mitral leaflets to the leftatrium), but on top of the mitral valve leaflets 24 a, 24 b. Whendeployed in this position, the mitral valve assembly exerts sufficientradial pressure outwardly to press into the native tissue, as theshape-memory material exerts an outward radial force to return theassembly to its expanded shape. As a result of the positioning of theflared end 14, the annulus 30 protrudes slightly inwardly past theflared end of the stent and acts as an annular mechanical stoppreventing upward movement of the mitral valve assembly 20. The amountof outward radial pressure exerted by the mitral valve assembly 20depends partly on the size of the stent and the type of shape-memorymaterial used. The stent size can depend on the particular patient andthe desired amount of pressure needed to hold the prosthetic mitralvalve in place. The tapered upper portion 12 of the mitral valveassembly 20 desirably is shaped to fit the contours of the native mitralvalve leaflets 24 a, 24 b, which bear against the outer surface of thestent and prevent downward motion of the assembly. Thus, due to theunique shape of the mitral valve assembly 20, it can be held in placesolely by the pressure exerted by the stent radially outwardly againstthe surrounding tissue without the use of hooks, prongs, clamps or othergrasping device.

When properly positioned, the valve assembly avoids or at leastminimizes paravalvular leakage. In tests performed on a porcine heart,approximately two pounds of force or greater were applied to stents inthe left atrial direction with little or no dislodgement, movement ordisorientation.

FIG. 5 shows an alternative positioning of the mitral valve assembly. Inthis position, the mitral valve assembly 20 can be secured above thenative mitral valve annulus 30. The mitral valve leaflets 24 a, 24 bstill prevent downward movement of the mitral valve assembly. However,to assist in preventing upward movement, the mitral valve assembly 20can be anchored using a tether 80 coupled between a lower portion of themitral valve assembly (such as by being tied to the stent) and a portionof the heart (e.g., an opposing wall). In the particular embodimentshown, the tether 80 extends through the apex 54 of the heart and issecured in place by an enlarged head portion 84 connected to the lowerend of the tether outside of the apex. The tether and/or head portioncan be formed of a bioresorbable material so that it eventuallydissolves after the stent has grown into the wall of the native mitralvalve.

FIG. 6 shows another embodiment of a mitral valve assembly 100 that maybe used with supra-annular positioning. In particular, an outer surfaceof a stent 102 includes anchoring members, such as, for example, prongs104 in the form of upwardly bent hooks, that can penetrate thesurrounding tissue to prevent upward migration of the assembly 100 whenin place. The anchoring members may be made from the same material asthe stent, but alternative materials may also be used.

FIG. 7 shows another embodiment of a stent 110 that can be used. In thisembodiment, an upper portion 112 of the stent is scalloped (i.e., theupper edge has one or more indented or cut-out portions 114). In somepatients, the pressure exerted by the upper rim of the stent on theanterior mitral leaflet can displace the mitral curtain and anteriorleaflet toward the left ventricular outflow track. The stent can bedeployed such that the anterior leaflet is generally positioned within acutout (scalloped) portion of the stent. In this manner, the scallopedstent 110 reduces the pressure on the leaflet to ensure there is noalteration of blood flow in the left ventricle.

FIGS. 8A-8D depict an embodiment of a transapical procedure forinserting the prosthetic mitral valve assembly into the native mitralvalve. The replacement procedure is typically accomplished by implantingthe prosthetic mitral valve assembly directly over the native leaflets,which are typically calcified. In this manner, the native leaflets 24 a,24 b can assist in securing the mitral valve assembly in place.

First, an incision is made in the chest of a patient and in the apex 54of the patient's heart. A guide wire 120 is inserted through the apex 54and into the left ventricle. The guide wire 120 is then directed upthrough the mitral valve 24 and into the left atrium 26. An introducer122 is advanced over the guide wire into the left atrium (see FIGS. 8Aand 8B). A delivery catheter 124 is inserted through the introducer (seeFIG. 8B). A prosthetic valve assembly 20 is retained in a crimped stateon the distal end portion of the delivery catheter as the valve assemblyand delivery catheter are advanced through the introducer. In onevariation, the introducer 122 is formed with a tapered distal endportion 123 to assist in navigating through the chordae tendinae. Thedelivery catheter 124 likewise can have a tapered distal end portion126.

In FIG. 8C, the introducer 122 is retracted relative to the mitral valveassembly 20 for deploying the mitral valve assembly from the distal endof the introducer. To pull the valve assembly 20 into position at theintended implantation site, the valve assembly desirably is partiallyadvanced out of the introducer to expose the flared upper end portion12, while the remainder of the valve assembly remains compressed withinthe introducer (as shown in FIG. 8C). As shown, the flared end portionexpands when advanced from the distal end of the introducer. Thedelivery catheter 124 and the introducer 122 can then be retractedtogether to pull the flared end into the desired position (e.g., justbelow the annulus of the native valve). Thereafter, the introducer canbe further retracted relative to the delivery catheter to advance theremaining portion of the valve assembly 20 from the introducer, therebyallowing the entire assembly to expand to its functional size, as shownin FIG. 8D. The introducer and catheter can then be withdrawn from thepatient.

Alternatively, the mitral valve assembly can be fully expanded directlyin place at the implantation site by first aligning the valve assemblyat the implantation site and then retracting the introducer relative tothe delivery catheter to allow the entire valve assembly to expand toits functional size. In this case, there is no need to pull the mitralvalve assembly down into the implantation site. Additional details ofthe transapical approach are disclosed in U.S. Patent ApplicationPublication No. 2007/0112422 (mentioned above).

In another embodiment, the valve assembly 20 can be mounted on anexpandable balloon of a delivery catheter and expanded to its functionalsize by inflation of the balloon. When using a balloon catheter, thevalve assembly can be advanced from the introducer to initially positionthe valve assembly in the left atrium 26. The balloon can be inflated tofully expand the valve assembly. The delivery catheter can then beretracted to pull the expanded valve assembly into the desiredimplantation site (e.g., just below the annulus of the native valve). Inanother embodiment, the balloon initially can be partially inflated topartially expand the valve assembly in the left atrium. The deliverycatheter can then be retracted to pull the partially expanded valve intothe implantation site, after which the valve assembly can be fullyexpanded to its functional size.

Mitral regurgitation can occur over time due to the lack of coaptationof the leaflets in the prosthetic mitral valve assembly. The lack ofcoaptation in turn can lead to blood being regurgitated into the leftatrium, causing pulmonary congestion and shortness of breath. Tominimize regurgitation, the leaflets of the valve assembly can beconnected to one or more tension members that function as prostheticchordae tendinae.

FIG. 9 , for example, shows an embodiment comprising a prosthetic mitralvalve assembly 152 having leaflets 154. Each leaflet 154 can beconnected to a respective tension member 160, the lower ends of whichcan be connected at a suitable location on the heart. For example, thelower end portions of tension members 160 can extend through the apex 54and can be secured at a common location outside the heart. Tensionmembers may be attached to or through the papillary muscles. The lowerends of tension members can be connected to an enlarged head portion, oranchor, 164, which secures the tension members to the apex. Tensionmembers 160 can extend through a tensioning block 166. The tensioningblock 166 can be configured to slide upwardly and downwardly relative totension members 160 to adjust the tension in the tensioning members. Forexample, sliding the tensioning block 166 upwardly is effective to drawthe upper portions of the tension members closer together, therebyincreasing the tension in the tension members. The tensioning block 166desirably is configured to be retained in place along the length of thetension members, such as by crimping the tensioning block against thetension members, once the desired tension is achieved. The tensionmembers can be made of any suitable biocompatible material, such astraditional suture material, GORETEX®, or an elastomeric material, suchas polyurethane. The tension members 160 further assist in securing thevalve assembly in place by resisting upward movement of the valveassembly and prevent the leaflets 154 from everting so as to minimize orprevent regurgitation through the valve assembly. As such, the tetheringde-stresses the moveable leaflets, particularly during ventricularsystole (i.e., when the mitral valve is closed). Alternatively or inaddition, the stent 10 can be connected to one or more tension members160 for stabilizing the mitral valve assembly during the cyclic loadingcaused by the beating heart.

FIG. 10 shows another embodiment of a mitral valve assembly 152 havingprosthetic chordae tendinae. The prosthetic chordae tendinae comprisefirst and second tension members 170 connected to a respective leaflet154 of the valve assembly. As shown, the lower end portions 172 of eachtension member 170 can be connected at spaced apart locations to theinner walls of the left ventricle, using, for example, anchor members174. A slidable tensioning block 176 can be placed over each tensionmember 170 for adjusting the tension in the corresponding tensionmember. In certain embodiments, each tension member 170 can comprise asuture line that extends through a corresponding leaflet 154 and has itsopposite ends secured to the ventricle walls using anchor members 174.

In particular embodiments, the anchor member 174 can have a plurality ofprongs that can grab, penetrate, and/or engage surrounding tissue tosecure the device in place. The prongs of the anchor member 174 can beformed from a shape memory material to allow the anchor member to beinserted into the heart in a radially compressed state (e.g., via anintroducer) and expanded when deployed inside the heart. The anchormember can be formed to have an expanded configuration that conforms tothe contours of the particular surface area of the heart where theanchor member is to be deployed, such as described in co-pendingapplication Ser. No. 11/750,272, published as US 2007/0270943 A1, whichis incorporated herein by reference. Further details of the structureand use of the anchor member are also disclosed in co-pendingapplication Ser. No. 11/695,583 to Rowe, filed Apr. 2, 2007, which isincorporated herein by reference.

Alternative attachment locations in the heart are possible, such asattachment to the papillary muscle (not shown). In addition, variousattachment mechanisms can be used to attach tension members to theheart, such as a barbed or screw-type anchor member. Moreover, anydesired number of tension members can be attached to each leaflet (e.g.,1, 2, 3 . . . etc.). Further, it should be understood that tensionmembers (e.g., tension members 160 or 170) can be used on any of theembodiments disclosed herein.

As discussed above, FIGS. 9-10 show the use of tension members that canmimic the function of chordae. The tethers can have several functionsincluding preventing the valve from migrating into the left atrium,de-stressing the leaflets by preventing eversion, and preservingventricular function by maintaining the shape of the left ventricle. Inparticular, the left ventricle can lose its shape over time as thenatural chordae become stretched or break. The artificial chordae canhelp to maintain the shape. Although FIGS. 9 and 10 show a tricuspidvalve, a bicuspid valve can be used instead. Particular bicuspid valvesare shown in FIGS. 12-16 .

FIG. 11 shows another embodiment of a mitral valve assembly 190including a valve 192 and a stent 194 (shown partially cut-away toexpose a portion of the valve). Tension members, shown generally at 196,can be connected between leaflets 198, 200 of the valve 192 and thestent itself. Only two leaflets are shown, but additional tensionmembers can be used for a third leaflet in a tricuspid valve. In theillustrated embodiment, the tension members 196 can include groups 202,204 of three tension members each. The three tension members 196 ofgroup 202 can be attached, at one end, to leaflet 198 at spacedintervals and converge to attach at an opposite end to a bottom 206 ofthe stent 194. Group 204 can be similarly connected between leaflet 200and the bottom 206 of the stent 194. The tension members 196 can be madeof any suitable biocompatible material, such as traditional suturematerial, GORE-TEX®, or an elastomeric material, such as polyurethane.The tension members can prevent the leaflets 198, 200 from everting soas to minimize or prevent regurgitation through the valve assembly. Assuch, the tension members de-stress the moveable portions of theleaflets when the leaflets close during systole without the need toconnect the tension members to the inner or outer wall of the heart.

Although groups of three tension members are illustrated, otherconnection schemes can be used. For example, each group can include anydesired number of tension members (e.g., 1, 2, 3, . . . etc.).Additionally, the tension members can connect to any portion of thestent 194 and at spaced intervals, if desired. Likewise, the tensionmembers can connect to the leaflets at a point of convergence, ratherthan at spaced intervals. Further, the tension members can be used onbicuspid or tricuspid valves. Still further, it should be understoodthat tension members extending between the stent and the leaflets can beused on any of the embodiments disclosed herein.

FIGS. 12-14 show another embodiment of a mitral valve assembly 220including a bicuspid valve 222 mounted within a stent 224. The bicuspidvalve 222 can include two unequally-sized leaflets, 226, 228. FIG. 12shows a perspective view of the mitral valve assembly 220 with thebicuspid valve 222 in an open position with blood flow shown bydirectional arrow 230. FIG. 14 shows a top view of the mitral valveassembly 220 with the valve 222 in the open position. FIG. 13 shows atop view of the mitral valve assembly 220 with the bicuspid valve 222 ina closed position. The leaflet 226 is shown as a larger leaflet thanleaflet 228 with the leaflets overlapping in a closed or at-restposition. The overlapping configuration can provide sufficient closureof the valve to prevent central or coaptation leakage and can enhancevalve durability by eliminating or minimizing impacts on the leaflettouching or coaptation. The bicuspid valve 222 can be used with any ofthe stent configurations described herein.

FIGS. 15 and 16 show another embodiment of a mitral valve assembly 240including a bicuspid valve 242 mounted within a stent 243. Tensionmembers, shown generally at 244, can be connected between leaflets 246,248 of the valve and the stent itself. Leaflet 246 is shown as a largerleaflet that overlaps leaflet 248. FIG. 15 shows the mitral valveassembly 240 in a closed position with the tension members 244 at fullextension. FIG. 16 shows the bicuspid valve 242 in the open positionwith the tension members 244 in a relaxed or slack state. Although thetension members 244 are shown attached at the same relative verticalposition or height on the stent 243, the tension members 244 can beattached asymmetrically relative to each other. In other words, thetension members 244 can be attached at different heights along thelength of the stent. Additionally, the tension members 244 can differ inlength in order to achieve the asymmetrical coupling between theleaflets 246, 248 and the stent 243. The tensioning members 244 can beused on any of the mitral valve assembly embodiments described herein.

FIG. 17 shows a top view of a mitral valve assembly 260 having anon-uniform cross-sectional shape. The mitral valve assembly 260 canhave a shape configured to conform to the natural opening of the nativemitral valve. For example, the mitral valve assembly 260 can have asubstantially “D” shape, with a substantially straight portion 262 and asubstantially curved portion 264. When implanted, the substantiallystraight portion 262 can extend along the anterior side of the nativemitral valve and the substantially curved portion 264 of the stent canextend along the posterior side of the native mitral valve. Other shapesmay also be used.

Having illustrated and described the principles of the illustratedembodiments, it will be apparent to those skilled in the art that theembodiments can be modified in arrangement and detail without departingfrom such principles.

Although the transapical procedure shown in FIGS. 8A-8D illustratespositioning and deployment of mitral valve assembly 20, otherembodiments of the mitral valve assembly disclosed herein can beimplanted using the same procedure, such as the mitral valve assembly100 of FIG. 6 , or a mitral valve assembly using the stent of FIG. 7 .

Further, although the mitral valve assembly 20 is shown generallycircular in cross section, as noted above, it can have a D-shape, anoval shape or any other shape suitable for fitting the contours of thenative mitral valve. Furthermore, although the mitral valve assembly isshown as having a flared upper end, other embodiments are contemplated,such as, for example, wherein the stent is flared at both ends or has asubstantially cylindrical shape. Furthermore, the stent may be coated toreduce the likelihood of thrombi formation and/or to encourage tissueingrowth using coatings known in the art. Still further, it iscontemplated that the stent may be replaced with an alternativestructure, such as an expandable tubular structure, which is suitablefor anchoring the prosthetic valve member in the heart.

Still further, although a transapical procedure is described in detailin FIGS. 8A-8D, other procedures can be used in conjunction with theabove-described embodiments. For example, U.S. Patent Publication2004/0181238, to Zarbatany et al., entitled “Mitral Valve Repair Systemand Method for Use”, which is hereby incorporated by reference,discloses a percutaneous delivery approach. A guidewire capable oftraversing the circulatory system and entering the heart of the patientcan be introduced into the patient through an endoluminal entry point,such as the femoral vein or the right jugular vein. The guidewire canthen be directed into the right atrium where it traverses the rightatrium and punctures the atrial septum using a trans-septal needle. Theguidewire can then be advanced through the atrial septum, through theleft atrium and through the mitral valve. Once the guidewire is properlypositioned, a guide catheter can be attached to the guidewire andadvanced proximate the native mitral valve. A delivery catheter fordelivery of the prosthetic mitral valve can then be advanced through theguide catheter to deploy the prosthetic valve within the native mitralvalve. Various delivery catheters can be used, such as those describedin Zarbatany, as well as those described U.S. Patent Publication2007/0088431, to Bourang et al., entitled “Heart Valve Delivery SystemWith Valve Catheter” and U.S. Patent Publication U.S. 2007/0005131, toTaylor, entitled “Heart Valve Delivery System”, both of which are herebyincorporated by reference.

In view of the many possible embodiments, it will be recognized that theillustrated embodiments include only examples of the invention andshould not be taken as a limitation on the scope of the invention.Rather, the invention is defined by the following claims. We thereforeclaim as the invention all such embodiments that come within the scopeof these claims.

We claim:
 1. A prosthetic heart valve assembly comprising: a radiallyself-expandable stent made from a shape memory material, wherein thestent comprises a flared upper portion defining an inlet end of thestent, a lower portion defining an outlet end of the stent, and anintermediate portion between the upper and lower portions, the stenthaving a passageway extending therethrough, wherein an entire extent ofthe stent downstream of the inlet end has a smaller diameter than adiameter of the inlet end, the stent further comprising a plurality ofprongs disposed along an outer surface thereof; wherein the prongs arearranged in a plurality of rows of prongs, each row comprising aplurality of prongs that are circumferentially spaced from each other,wherein the rows are spaced from each other in a direction extendingalong a length of the stent and wherein all of the prongs have tipspointing toward the inlet end; and a valve portion positioned in thepassageway, wherein the valve portion comprises a plurality of leafletsthat permit the flow of the blood through the prosthetic heart valveassembly in a direction from the inlet end to the outlet end and blockthe flow of blood in the opposite direction; wherein the prostheticheart valve assembly is configured to be retained in a radiallycompressed state within a delivery catheter and radially self-expand toa radially expanded state when deployed from the delivery catheter;wherein the prosthetic heart valve assembly is configured such that whenthe prosthetic heart valve assembly is deployed within a native heartvalve between an atrium and a ventricle of the heart, the prongs canpenetrate surrounding tissue for preventing upward migration of theprosthetic heart valve assembly toward the atrium and the flared upperportion can contact a supra-annular surface of an annulus of the nativevalve to prevent downward migration of the prosthetic heart valveassembly toward the ventricle.
 2. The prosthetic heart valve assembly ofclaim 1, wherein the stent has an intermediate portion between the inletand outlet ends, wherein a diameter of the outlet end is smallerdiameter than a diameter of the intermediate portion.
 3. The prostheticheart valve assembly of claim 1, wherein the stent tapers from the inletend to the intermediate portion and further tapers from the intermediateportion to the outlet end such that a diameter of the intermediateportion is less than the diameter of the inlet end but greater than adiameter of the outlet end.
 4. The prosthetic heart valve assembly ofclaim 1, wherein the heart valve assembly is configured to be insertedinto the heart with the delivery catheter using a transapical procedure.5. The prosthetic heart valve assembly of claim 1, wherein the heartvalve assembly is configured to be advanced through a femoral vein andinto the heart with the delivery catheter.
 6. The prosthetic heart valveassembly of claim 1, wherein the plurality of leaflets comprises threeleaflets made from pericardium.
 7. The prosthetic heart valve assemblyof claim 1, wherein the prongs are made from the same material as thestent.
 8. The prosthetic heart valve assembly of claim 1, wherein thestent has a truncated conical shape.
 9. The prosthetic heart valveassembly of claim 1, wherein the inlet end is devoid of prongs.
 10. Aprosthetic heart valve assembly, comprising: a self-expandable stenthaving an inlet end and an outlet end and a passageway extendingtherethrough, wherein a largest diameter of the stent is at the inletend, the stent including a plurality of prongs disposed along an outersurface thereof, wherein the prongs are arranged in a plurality of rows,each row comprising a plurality of circumferentially spaced prongs andwherein the rows are spaced apart in a longitudinal direction; whereinthe inlet end is circular in shape; wherein the outlet end is circularin shape; wherein the inlet end of the stent is devoid of prongs; and avalve portion positioned within the passageway, the valve portioncomprising a plurality of leaflets for permitting blood to flow throughthe passageway from the inlet end to the outlet end while blocking flowin the opposite direction; wherein the stent includes a flared upperportion shaped for placement along a supra-annular surface of an annulusfor preventing downward migration of the prosthetic valve assembly intoa ventricle and wherein each of the prongs has a tip pointing toward theinlet end for penetrating surrounding tissue and preventing upwardmigration of the prosthetic heart valve assembly toward an atrium. 11.The prosthetic heart valve assembly of claim 10, wherein the stent isformed from Nitinol.
 12. The prosthetic heart valve assembly of claim10, wherein the plurality of leaflets comprises three leaflets made frompericardium.
 13. The prosthetic heart valve assembly of claim 10,wherein the diameter of the inlet end is a first diameter, the outletend has a second diameter, and the stent has a third diameter at alocation along the stent between the inlet and outlet ends, wherein thesecond diameter is less than the third diameter and the third diameteris less than the first diameter.
 14. The prosthetic heart valve assemblyof claim 10, wherein the prosthetic valve assembly is configured to beheld in place within a native heart valve without clamping on to theannulus.
 15. A prosthetic heart valve assembly, comprising: aself-expandable stent having an inlet end and an outlet end and apassageway extending therethrough, the stent including a plurality ofprongs disposed along an outer surface thereof, wherein the prongs arearranged in a plurality of rows, each row comprising a plurality ofcircumferentially spaced prongs and wherein the rows are spaced apart ina longitudinal direction; and a valve portion positioned within thepassageway, the valve portion comprising a plurality of leaflets forpermitting blood to flow through the passageway from the inlet end tothe outlet end while blocking flow in the opposite direction; whereinthe stent includes a flared upper portion shaped for placement along asupra-annular surface of an annulus for preventing downward migration ofthe prosthetic valve assembly into a ventricle and wherein each of theprongs has a tip pointing toward the inlet end for penetratingsurrounding tissue and preventing upward migration of the prostheticheart valve assembly toward an atrium.
 16. The prosthetic heart valveassembly of claim 15, wherein the plurality of leaflets comprises threeleaflets made from pericardium.
 17. The prosthetic heart valve assemblyof claim 15, wherein the inlet end is circular in shape.
 18. Theprosthetic heart valve assembly of claim 15, wherein the outlet end iscircular in shape.
 19. The prosthetic heart valve assembly of claim 18,wherein the inlet end has a first diameter, the outlet end has a seconddiameter, and the stent has a third diameter at a location along thestent between the inlet and outlet ends, wherein the second diameter isless than the third diameter and the third diameter is less than thefirst diameter.
 20. The prosthetic heart valve assembly of claim 15,wherein the flared upper portion tapers from a first diameter at theinlet end to a second diameter, less than the first diameter, at alocation on the stent downstream of the inlet end.